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Extended-Release Tacrolimus (Envarsus XR) Wins FDA Nod for Kidney Transplant Patients

Treatment offers greater bioavailability compared with Prograf

The FDA has said “okay” to tacrolimus extended-release tablets (Envarsus XR, Veloxis Pharmaceuticals) for the prophylaxis of organ rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects the drug to be available to physicians in the U.S. in the fourth quarter of 2015.

The FDA’s approval was based on data from two phase III trials and several phase II trials in kidney transplant recipients. In all of these studies, extended-release tacrolimus dosed once daily demonstrated significantly greater bioavailability and a flatter pharmacokinetic profile compared with the current leading transplant drug, Prograf (immediate-release tacrolimus, Astellas Pharma), dosed twice-daily.

Envarsus XR tablets are not interchangeable or substitutable with other tacrolimus extended-release or immediate-release products.

The following warnings and precautions are associated with the use of extended-release tacrolimus:

  • Immunosuppressants, including extended-release tacrolimus, increase the risk of lymphomas and other malignancies, particularly of the skin.
  • Immunosuppressants, including extended-release tacrolimus, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious or fatal outcomes.
  • Extended-release tacrolimus has caused new-onset diabetes after transplant in kidney transplant patients, which may be reversible in some patients. African-American and Hispanic kidney transplant patients are at increased risk.
  • Extended-release tacrolimus, like other calcineurin inhibitors, can cause acute or chronic nephrotoxicity.
  • Extended-release tacrolimus may cause a spectrum of neurotoxicities. The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; other neurotoxicities include tremors, paresthesias, headache, changes in mental status, and changes in motor and sensory functions.
  • Mild-to-severe hyperkalemia, which may require treatment, has been reported with tacrolimus, including the extended-release formulation.
  • Hypertension is a common adverse reaction to treatment with extended-release tacrolimus and may require antihypertensive therapy.
  • The concomitant use of strong cytochrome P450-3A inducers may increase the metabolism of tacrolimus, leading to lower whole-blood trough concentrations and a greater risk of organ rejection.
  • Extended-release tacrolimus may prolong the QT/QTc interval and cause torsade de pointes.

Source: Veloxis Pharmaceuticals; July 13, 2015.

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